clinical Trials - HIV / AIDS

TMC 125 Early Access Program:

This clinical trial is designed to provide early access to TMC 125 in combination with other antiretrovirals in treatment-experienced HIV-1 infected subjects with limited treatment options. After reading the criteria if you are interested in this trial and/or you have additional questions, please call us at (702) 384-9101.

The following criteria are necessary for inclusion into this trial:

Subject of Legal Authorized Representative has voluntarily given informed consent before initiation of trial procedures.
Subject has documented HIV-1 infection.
Male or female subject over 18 years of age.
Subject has limited treatment options due to virological failure or intolerance to multiple ARV regimens.
Subject is at least 3-class experienced.
Subject has previously received 2 different PI-based regimens.
Subject is unable to use currently approved NNRTIs due to resistance and/or intolerance.
Subject, if currently receiving an ARV regimen, is not achieving adequate virologic suppression on his/her current regimen.

The following criteria would exclude a patient from this trial:

Primary HIV infection.
Prior or current participation in DUET trials (TMC125-C206 or TMC125-C216).
Any condition (including but not limited to alcohol and drug use), which, in the opinion of the investigator, could compromise the subject’s safety or adherence to the protocol.
Use of disallowed concomitant therapy, including disallowed ARVs.
Use of non-ARV investigational medications within the 30 days prior to baseline visit.
Use of investigational ARVs, unless stated as an exception.
Any active clinically significant disease or finding during screening of medical history or physical examination that is not either resolved or stabilized for at least 30 days before the screening phase of the trial.
Acute viral hepatitis, including but not restricted to A, B or C.
Pregnant or breast-feeding female.
Female subject of childbearing potential not using effective non-hormonal birth control methods or not willing to continue practicing these birth control methods from screening until the last trial related activity.
Subjects with the following laboratory abnormalities as defined by a standardized grading scheme base on the Division of AIDS (DAIDS) grading table:

Hemoglobin < 7.4 g/dL
Absolute neutrophil count < 500/mm3
Platelets < 25,000/mm3
Prothrombin time > 1.5 ULN
Alkaline phosphatase > 5 x ULN
Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) > 5 x ULN
Bilirubin > 5 x ULN
Lipase > 3 x ULN
Amylase > 5 x ULN
Creatinine > 1.8 ULN

Subjects with clinical or laboratory evidence of significantly decreased hepatic function.
Previously demonstrated clinically significant allergy or hypersensitivity to any of the excipients of the investigational medication (TMC125).